TOURETTE SYNDROMEPhase 1NCT02674321
A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)
A Phase 1 study testing SD-809 in people with TOURETTE SYNDROME, run by Auspex Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the pharmacokinetic of SD-809 and its metabolites. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- TOURETTE SYNDROME
- What is being tested?
- SD-809
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12 to 18 years of age, inclusive, at Screening.
- Patient has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnosis of Tourette Syndrome and has manifested motor and phonic tics within 3 months before the Screening visit
- Patient has total tic score of ≥19 on the YGTSS
- Tic severity and frequency has been stable for at least 2 weeks before the Screening visit
- Willing to adhere to medication regimen and to comply with all procedures
- Patient is in good general health, as indicated by medical and psychiatric history and physical examination
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- Patient and parent/guardian have provided written, informed consent (and written assent, as appropriate)
- Female patients of childbearing potential agree to use an acceptable method of contraception
- Additional criteria apply, please contact the investigator for more information
Who cannot join
- Patient has a serious untreated or undertreated psychiatric illness
- Patient has a history of suicidal ideation or behavior
- Patient has received tetrabenazine, neuroleptics, benzodiazepines, topiramate, dopamine receptor antagonists within 14 days of Screening or Baseline; or botulinum toxin within 3 months of Screening or Baseline
- Patient is being treated with deep brain stimulation for control of tics
- Patient has a progressive or degenerative neurological disorder or a structural disorder of the brain
- Patient has participated in an investigational drug or device trial within 30 days of Screening
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- Patient is pregnant or breastfeeding at Screening or Baseline
- Patient has a history of alcohol or substance abuse in the previous 12 months, as defined in the DSM-V
- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
1 site in 1 country.
United States1 site
Teva Investigational Site #101
Houston, Texas, 77030
About this study
Official title: A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome
The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the pharmacokinetic of SD-809 and its metabolites.
- Conditions
- TOURETTE SYNDROME
- Being tested
- SD-809
- Keywords
- Tourette Syndrome, adolescents
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-809Drug
| Study group | Role | What they receive |
|---|---|---|
| SD-809 | Experimental | • SD-809 tablets taken once or twice daily for 8 weeks, includes a dose titration period and a maintenance period. Receives: Drug: SD-809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.
Measured: 8 weeks
Secondary outcomes (5)
Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)
Measured: Baseline, Weeks 2, 4 and 8
Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS)
Measured: Baseline, Weeks 2, 4, and 8
Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS)
Measured: Baseline, Weeks 2, 4, and 8
Change from Baseline in Tourette Syndrome Clinical Global Impression
Measured: Baseline, Weeks 2, 4, and 8
Patient Global Impression of Change (TS-PGIC)
Measured: Weeks 2, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TOURETTE SYNDROMEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auspex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674321
- Sponsor's protocol ID
- SD-809-C-17
- Status last verified
- Nov 2021
- First submitted
- 2 Feb 2016
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome
- ClinicalTrials.gov ID
- NCT02674321
- Acronym / sponsor ID
- SD-809-C-17
- Conditions
- TOURETTE SYNDROME
- Keywords
- Tourette Syndrome, adolescents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Auspex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the pharmacokinetic of SD-809 and its metabolites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SD-809 | Experimental | Drug: SD-809• SD-809 tablets taken once or twice daily for 8 weeks, includes a dose titration period and a maintenance period. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 12 to 18 years of age, inclusive, at Screening.
- Patient has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnosis of Tourette Syndrome and has manifested motor and phonic tics within 3 months before the Screening visit
- Patient has total tic score of ≥19 on the YGTSS
- Tic severity and frequency has been stable for at least 2 weeks before the Screening visit
- Willing to adhere to medication regimen and to comply with all procedures
Key exclusion criteria (9 listed)
- Patient has a serious untreated or undertreated psychiatric illness
- Patient has a history of suicidal ideation or behavior
- Patient has received tetrabenazine, neuroleptics, benzodiazepines, topiramate, dopamine receptor antagonists within 14 days of Screening or Baseline; or botulinum toxin within 3 months of Screening or Baseline
- Patient is being treated with deep brain stimulation for control of tics
- Patient has a progressive or degenerative neurological disorder or a structural disorder of the brain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SD-809 | Drug | SD-809 |
Primary outcome
Safety
Time frame: 8 weeks
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.
5 secondary outcomes
Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline, Weeks 2, 4 and 8
Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline, Weeks 2, 4, and 8
Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline, Weeks 2, 4, and 8
Change from Baseline in Tourette Syndrome Clinical Global Impression
Time frame: Baseline, Weeks 2, 4, and 8
Patient Global Impression of Change (TS-PGIC)
Time frame: Weeks 2, 4, and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SD-809 in people with TOURETTE SYNDROME, run by Auspex Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.